Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00005510

Trial Description

start of 1:1-Block title

Title

Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

AUTO-ACUSAR

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

There is inconclusive evidence whether acupuncture treatment is effective in the treatment
of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture
in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of
acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the
DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of
acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to
investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic
function in a sub-group of ACUSAR patients. Baseline values were compared to data from
matched healthy controls.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups
were included. Tests of autonomic functions included measurement of heart rate variability
during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a
cold pressure test (CPT) and cortisol awakening response before the first and the last of
twelve treatment sessions. Healthy matched controls underwent the same measurement once only

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005510
  •   2014/01/15
  •   2010/12/23
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01271595  (ClinicalTrials.gov)
  •   EA1/214/07a  (Charite University, Berlin, Germany)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Seasonal Allergic Rhinitis
  •   J30.2 -  Other seasonal allergic rhinitis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Other: sham acupuncture
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo, Active control
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Heart Rate Variability; time frame: 8 weeks; RMSSD, LF, HF, HR, blood pressure

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR); time frame: 8 weeks; Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2009/08/31
  •   60
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   45   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Female or male patients (aged 16-45 years) with seasonal allergic rhinitis,
clinically positive and test positive (skin-prick test and/or RAST) to grass and
birch pollen

- Patients with >2 years of moderate to severe SAR

- Positive skin-prick test and/or RAST (at least class 2) results

- Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year

- Patients must be able to complete a diary for self-evaluation of symptoms and
recording use of anti-symptomatic medication

- Use of, or indication for, oral antihistamines as anti-allergic medication

- Written informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Perennial SAR or other types of chronic rhinitis

- Allergic asthma and/or moderate to severe atopic dermatitis

- Active tuberculosis

- Auto-immune disorders

- Severe chronic inflammatory diseases

- History of anaphylactic reactions

- Hypersensitivity to Rescue medication or related drugs used in study related drugs

- Specific immunotherapy >3 years

- Simultaneous participation in other clinical trials

- Serious acute or chronic organic disease or mental disorder

- Pregnancy or breast feeding

- Allergy desensitisation therapy (current, during the past two years, or planned in
the next two years)

- Blood coagulation disorder and/or current use of anticoagulants

- Previous acupuncture treatment for SAR

- Any Complementary and alternative medicine treatment at the moment, in the last three
months or planned in the next two years

- intake of Beta-Blocker Medication

- use of pacemaker

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charite University, Berlin, Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
    • Benno Brinkhaus, Prof. Dr. 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
    • Benno Brinkhaus, Prof. Dr. 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.